Rubber band ligation system for treatment of hemorrhoids

ABSTRACT

A system including an anoscope having a first channel extending along a longitudinal axis and a second channel positioned at an angle to the first channel. For hemorrhoid treatment, an elastic band ligation device is insertable into the second channel, the elastic band ligation device carrying an elastic band and having an advancer movable in a distal direction to dislodge the elastic band.

This application claims priority from provisional application Ser. No.62/566,255, filed Sep. 29, 2017, the entire contents of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

This application relates to a system and method for treatment ofhemorrhoids.

2. Background

Internal hemorrhoids are normal, asymptomatic rectal vascular tissue.There are typically three or more internal hemorrhoids, which play arole in reducing the anal trauma during defecation and aiding in gas andstool continence. When hemorrhoids, however, enlarge and/or theirsurface becomes fragile (due to inflammation, infection, or otherfactors), they may bleed and/or prolapse outside of the anus, which maycause discomfort, pain, anemia, and other disturbing symptoms.

One of the common treatment methods of symptomatic hemorrhoids isreferred to as “rubber band ligation” which involves strangulation ofthe hemorrhoid itself and/or strangulation of its superior blood supplyby a special elastic rubber ring (band). The rubber band is placed ontothe target tissue using a rubber band ligator in the painless area ofthe anal canal, which is located anatomically proximal of (“above”) theso-called dentate line. The dentate line is a visible anatomical lineseparating the sensitive mucosa (located distally to the dentate line)from the non-sensitive (or less sensitive) mucosa (located proximally tothe dentate line). In the following few days after the rubber bandplacement, the tissue strangulated by the rubber band becomes necroticand falls off leaving a corresponding tissue defect, which then healsover the following weeks. If performed properly, this technique leads tothe decreased blood supply to the internal hemorrhoid and/or reductionof its size, resulting in improvement of the associated hemorrhoidalsymptoms.

Although, overall, the rubber band ligation technique for the treatmentof symptomatic internal hemorrhoids is considered fairly straightforwardamong experts, there are a number of technical and anatomical challengesand nuances which challenge an acquisition of the technical mastery.First, proper placement of the rubber band is critical. If the rubberband is placed too close to the dentate line (either distally orproximally) or too close to the underlying rectal muscle, it may lead toundesirable side effects such as severe pain, tenesmus, and or fainting,and can even in some instances lead to severe complications such asrectal perforation, infection, and/or severe bleeding. To avoid orminimize complications of the rubber band ligation procedure, the rubberband should be placed 2-2.5 cm proximally to the visualized dentate linein the non-sensitive area without any involvement of the underlyingrectal muscle.

In addition, the rubber band ligation technique requires an assistantwhich thereby requires coordination. That is, the technique requires anaccurate and well-controlled release of the rubber band by the operatorin the restricted field with limited view while orchestrating thisimportant maneuver with the assistant's movements.

One of the main technical challenges for an operator during the rubberband ligation technique is related to the need, while holding ananoscope, to pull on the target tissue with either forceps or thesuction tip and then, when “just the right amount” of the target tissueappears to be engaged, to release the rubber band onto the base of thepulled tissue. These maneuvers require coordinated manipulations of bothhands of the operator and possibly an assistant holding the anoscope. Inaddition, the view of the target area can be obscured by the instrumentsand the operator's own hands, further increasing the challenge of theprocedure.

While special hemorroidal forceps can provide the most accurate tissuemanipulation for application of elastic bands, the forceps require afairly advanced, expert dexterity. As an alternative, tissue suction canbe utilized, however, it requires dedicated suction equipment, which inturn requires access to an electrical source, the need for single usecomponents, and costly professional support and maintenance. Further,the amount of the suctioned tissue may need to vary from case to case,and the suction provided by the typical suction equipment is notsufficiently gauged to address this variable need. There is also noability in the typical suction equipment to “slightly release” thesuctioned tissue. This frequently leads to the excessive tissue suctionor repetitive repositioning of the suction tip until “just the rightamount” of the target tissue is engaged for rubber banding. Thus, inprior techniques, the operator cannot fully control the amount of tissuesuctioned.

In current procedures, an anoscope is inserted through the anal canaland instruments for treating the hemorrhoids are inserted through achannel of the anoscope to access the target hemorrhoidal tissue.However, a current problem includes a lack of technology for organizingand stabilizing the instruments within the anoscope. Also, in currentinstrumentation, the instruments often obstruct the clinician's view asthe clinician tries to view the tissue through the anoscope channel. Notonly can current instruments block the surgeon's direct view but theirstabilization relies on the clinician holding the instrument positionduring manipulation of the instrument. Holding the instrument inposition becomes more challenging as components of the instrument aremoved in an axial direction. If the axial position is not maintained andthe instrument moves during the procedure, its distance from the dentateline will change which results in the risks enumerated above. Thus, aclinician would like to have a view of the working space that is theleast obstructed as well as a system that can better ensure the desiredposition of the instrument is maintained during the procedure.

Therefore, there is a need for improvements to the rubber band ligationdevice and method, which would facilitate the accurate rubber bandplacement by an operator without requiring advanced manual skills. Inaddition, it would be further beneficial to eliminate the need for anassistant during the procedure which would not only reduce the cost ofthe procedure but avoid the risk of non-coordination of the operator andassistant. Moreover, there is a need to improve tissue manipulation aswell as a need to improve stabilization of the instruments andvisibility of the target area during the procedure.

SUMMARY OF THE INVENTION

The present invention overcomes the deficiencies and disadvantages ofthe prior art. The present invention advantageously provides a systemfor treating hemorrhoid tissue which provides a stabilizing platform fortreatment devices such as ligating instruments. The systems disclosedherein achieve such stabilization with minimizing obstruction ofvisibility. The systems disclosed herein also simplify the procedure.Advantages of the systems can be appreciated by the detailed descriptionherein.

In one aspect, the present invention provides a system for treatment ofhemorrhoids comprising an anoscope having a first channel extendingalong a longitudinal axis and a second channel positioned at an angle tothe first channel. An elastic band ligation device is insertable intothe second channel and carries an elastic band and has an advancermovable in a distal direction to dislodge the elastic band.

In some embodiments, an obturator is removably insertable into the firstchannel to aid insertion of the anoscope into the rectum.

In some embodiments, the elastic band ligation device comprises aplunger movable in a proximal direction within a tube of the device toeffect suctioning of target tissue. The elastic band in some embodimentsis positioned on an external surface of the device and the elastic bandligation device can include a tube and the advancer can be positionedexternal and concentric with the tube.

The system can include a first stop on a wall of the anoscope torestrict distal movement of the ligation device within the secondchannel and/or a second stop on the anoscope to restrict proximalmovement of the ligation device in the second channel. In someembodiments, rotation of the ligation device relative to the anoscope ina first direction enables the second stop to limit proximal movement. Insome embodiments, rotation of the ligation device relative to theanoscope in a first direction enables engagement with a portion of theinternal wall to limit proximal movement of the ligating device.

The anoscope can have a marker to indicate a distance from a dentateline of a patient.

In some embodiments, the second channel has a longitudinally extendingopening facing inferiorly; in other embodiments the second channel has alongitudinally extending channel facing laterally. In some embodiments,the second channel has fenestrations which can provide discrete spacedapart channel sections.

In accordance with another aspect of the present invention, a system fortreatment of hemorrhoids is provided comprising an anoscope having afirst channel extending along a longitudinal axis and a second channelpositioned at an angle to the first channel, the second channelintersecting the first channel so a distal opening of the second channelis in communication with the first channel. An elastic band ligationdevice is insertable into the second channel, the elastic band ligationdevice including a first tube and a tissue holder. The first tube ismovable to advance and dislodge an elastic band from the ligation deviceonto target tissue. The second channel stabilizes the ligation deviceand restricts lateral movement while enabling longitudinal movementwithin the second channel and the second channel enables access to thetarget tissue at an angle to a longitudinal axis of the first channel.In some embodiments, the first tube is an outer tube movable withrespect to a second tube inside the first tube.

In some embodiments, the tissue holder comprises a suction device. Thesuction device can include a plunger having a transverse distal platewherein proximal movement of the plunger pulls the target tissueproximally as the outer tube engages the target tissue. In someembodiments, a locking device is provided which includes an engagementstructure on the ligation device engagable with engagement structure ofthe anoscope to restrict axial movement of the ligation device withinthe anoscope. In some embodiments, engagement structure on the ligationdevice and anoscope restrict rotational movement of the ligating devicewithin the anoscope.

In accordance with another aspect of the present invention, a system forstabilizing an instrument during a hemorrhoid treatment procedure isprovided comprising an anoscope having a first channel extending along alongitudinal axis to provide direct visualization to a clinician througha length of the first channel and a second channel positioned at anangle to a longitudinal axis of the first channel to directinstrumentation inserted through the second channel at an angle to adistal end of the first channel to reduce obstruction of directvisualization through the first channel. The second channel further hasan engagement structure engageable with an instrument insertedtherethrough to restrict axial movement of the instrument to therebymaintain the axial position of the instrument with respect to a dentateline of a patient.

In some embodiments, the second channel includes structure to limitrotation of an instrument within the second channel. In someembodiments, a wall of the second channel is non-continuous to provideopenings for visualization of the instrument during insertion throughthe second channel.

In accordance with another aspect of the present invention, an anoscopeis provided having an outer wall dimensioned and configured forinsertion into the anal canal, the anoscope having a proximal end, adistal end, a first channel and a second channel. The first channelextends longitudinally through the anoscope and has a proximal openingand a distal opening. The second channel is positioned at an angle to alongitudinal axis of the first channel and has a proximal opening and adistal opening, the distal opening of the second channel communicatingwith the first channel and the second channel dimensioned and configuredto receive a treatment device such as a ligation device.

In some embodiments, the anoscope includes a stop to limit distalmovement and/or limit proximal movement of a ligation device insertedthrough the second channel. The anoscope can also in some embodimentslimit rotational movement of a ligation device positioned in the secondchannel.

In some embodiments, the second channel is on a first side of theanoscope and a distal end of the anoscope forms a window on a secondside, wherein a distal edge on the first side is distal of an opposingedge of the anoscope on the second side. In some embodiments, the firstand second channels share a common wall. In some embodiments, the secondchannel has a wall having a plurality of fenestrations to provide aseries of spaced discrete longitudinally aligned channels. In someembodiments, the second channel includes a longitudinally extending slotto enable lateral insertion of the ligation device into the secondchannel.

In accordance with another aspect of the present invention, an elasticband ligation device is provided comprising a first tube, a plungerpositioned within the first tube, and a second tube positioned over thefirst tube. The first tube is configured to hold an elastic band intension, wherein the plunger is retractable to suction hemorrhoid tissueand pull hemorrhoid tissue proximally, and the second tube isadvanceable to advance the elastic band from the first tube onto thetarget tissue,

The device in some embodiments includes an engagement member forinteracting with an engagement surface on an anoscope through which thedevice is insertable to restrict movement of the device within theanoscope. The device can include a marker for indicating a distance froma dentate line of a patient.

In some embodiments, the second tube has a distal edge which contactsthe tensioned elastic band to advance it from the first tube. Theplunger in some embodiments has a transverse plate at a distal end toengage the hemorrhoid tissue.

In accordance with another aspect of the present invention, a method forapplying an elastic band to hemorrhoidal tissue is provided comprising:

-   -   a) providing an anoscope having a first longitudinal channel and        a second channel extending at an angle to the first channel;    -   b) inserting the anoscope through the anal canal adjacent        hemorrhoid tissue and anatomically proximal of a dentate line of        a patient;    -   c) inserting a ligating device through the second channel of the        anoscope; and    -   d) advancing the elastic band from the ligating device onto the        hemorrhoid tissue.

In some embodiments, the step of advancing the elastic band comprisesthe step of advancing an outer tube of the ligating device in contactwith the elastic band.

In some embodiments, the method includes step of locking the ligatingdevice to the anoscope to restrict axial and/or rotational movement ofthe ligating device within the anoscope. In some embodiments, theligating device is rotatable with respect to the anoscope to engage thelocking device to restrict axial movement.

In some embodiments, the method further comprises the step of retractingan inner member of the ligating device to suction the hemorrhoid tissueand retract the hemorrhoid tissue into the ligating device. The step ofadvancing the elastic band is preferably performed subsequent to thestep of retracting the inner member to suction the hemorrhoid tissue.

In some embodiments, the step of inserting the ligating device includesadvancing the device through the second channel until it contacts a stopof the anoscope.

In some embodiments, the method includes the step of visualizing theligating device though an opening in the second channel as it isadvanced through the second channel. In some embodiments, the step ofinserting the ligating device through the second channel includesinserting the ligating device through a proximal opening in the secondchannel; in other embodiments, the step of inserting the ligating devicethrough the second channel includes inserting the ligating devicelaterally through a longitudinally extending opening in the secondchannel.

In some embodiments, the anoscope and second channel are configured sothat when the anoscope is inserted so a distal edge is at the dentateline, a tip of the ligating device inserted through the second channelto contact the target tissue will be positioned about 2 cm to about 2.5cm from the distal edge of the anoscope and the dentate line of thepatient. In some embodiments, a vertex of an imaginary triangle formedby an intersection of an extended longitudinal axis of the secondchannel and an extended edge of the anoscope is between about 2 cm andabout 2.5 cm from the dentate line of the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

So that those having ordinary skill in the art to which the subjectinvention appertains will more readily understand how to make and usethe surgical apparatus disclosed herein, preferred embodiments thereofwill be described in detail hereinbelow with reference to the drawings,wherein:

FIG. 1 is a side perspective view of a first embodiment of the anoscopeof the present invention;

FIG. 2A is a front perspective view of an alternate embodiment of theanoscope of the present invention showing an internal channel openinferiorly;

FIG. 2B is a front perspective view of an alternate embodiment of theanoscope of the present invention showing an internal channel openlaterally;

FIG. 2C is a front perspective view of another alternate embodiment ofthe anoscope of the present invention having a closed continuouschannel;

FIG. 3A is a cross-sectional view showing an obturator positioned withinthe main channel of the anoscope of FIG. 1 to aid insertion through theanal canal to access the target hemorrhoidal tissue;

FIG. 3B is a cross-sectional view similar to FIG. 3A showing theligation device of the present invention inserted through the channel ofthe anoscope of FIG. 1 (the obturator has been removed);

FIG. 3C is a cross-sectional view showing the ligation device of thepresent invention inserted through the channel of the anoscope of FIG.2C (the obturator has been removed);

FIG. 3D is a cross-sectional view showing the ligation device of thepresent invention inserted through the channel of the anoscope of FIG.2A (the obturator has been removed);

FIG. 4 is a cross-sectional view similar to FIG. 3B showing the ligationdevice of the present invention fully inserted through the anoscope;

FIG. 5 is a close-up view of the area of detail identified in FIG. 4showing the ligation device inserted through the channel of the anoscopeof FIG. 2A prior to engagement with the stop/lockout;

FIG. 6 is a view similar to FIG. 5 showing the ligation device furtherinserted through the channel to engage the distal stop and align withthe radial slot, the arrow indicating the rotational movement of theligation device;

FIG. 7 is a view similar to FIG. 6 showing the ligation device rotatedwithin the channel to engage the proximal stop and interlock with theanoscope to restrict axial movement;

FIG. 8A is a view similar to FIG. 5 showing the ligation device insertedthrough the channel of the anoscope of FIG. 2C prior to engagement withthe stop/lockout;

FIG. 8B is a view similar to FIG. 8A showing the outer tube with awindow;

FIG. 9 is a cross-sectional view showing the ligation device extendingthrough the anoscope of FIG. 1 and showing the inner tube and plungerplate engaged with the hemorrhoid tissue;

FIG. 10 is a view similar to FIG. 9 showing the plunger retracted tosuction target tissue within the inner tube;

FIG. 11 is a view similar to FIG. 10 showing the plunger slightlyadvanced to release some of the suctioned tissue;

FIG. 12 is a view similar to FIG. 10 showing the outer tube advanced toadvance the elastic band around the target tissue;

FIG. 13 is a view similar to FIG. 12 showing the plunger in the initialposition and the elastic band placed around the target tissue;

FIG. 14 is a view similar to FIG. 13 showing the ligation device beingwithdrawn from the anoscope;

FIG. 15 is a view similar to FIG. 14 showing the anoscope beingwithdrawn from the rectum;

FIGS. 16 and 17 are perspective views showing the ligation deviceinserted laterally into the internal channel of the anoscope of FIG. 2A;

FIG. 18 is a perspective view showing the ligation device insertedlongitudinally through the proximal opening of the internal channel ofthe anoscope of FIG. 2A

FIG. 19 is a side perspective view of an alternate embodiment of theligation device of the present invention having a bent distal tip;

FIG. 20 is a flow chart depicting the steps of one embodiment of themethod of the present invention;

FIG. 21 is a side perspective view of an anoscope of another alternateembodiment of the present invention;

FIG. 22A is a side perspective view of an anoscope of another alternateembodiment of the present invention; and

FIG. 22B is view similar to FIG. 22A showing a ligation device insertedthrough the channel with the tip a fixed distance proximal of thedentate line.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The systems and methods of the present invention simplify the rubberband ligation procedure and advantageously eliminate the need for anassistant. The systems of the present invention also improve theorganization and stability of the instrumentation to enable widerphysician use of the system. Further, the systems of the presentinvention improve the clinician's visibility of the target tissue. Thesystems disclosed herein achieve the foregoing by providing a) ananoscope with a dedicated channel for a ligating device or otherinstruments (devices); and b) a ligating device (instrument) insertablethough the dedicated channel. The ligating device (also referred toherein as the ligation device or ligator) can in some embodiments in andof itself suction the target hemorrhoidal tissue and apply an elasticband to the hemorrhoidal tissue. The ligating device can also in someembodiments lock to the anoscope, thereby freeing a hand of the operatoror assistant which would otherwise have to hold the components and alsoensuring the critical positioning of the ligating device relative to thedentate line is maintained during the procedure. The tissue suctioningand holding capabilities of the ligating device of these embodimentsalso improve tissue manipulation. The features of the anoscope andligating device of the present invention are discussed in detail below,along with the method of use.

Thus, the technology taught herein provides one or more of 1) anorganization of the hemorrhoid treatment instrument(s), such as aligating device, e.g., a rubber band ligator, to maximize stability andmaneuverability and visualization of the hemorrhoidal tissue; 2)interlocking components to restrict movement of the hemorrhoid treatmentinstrument to free a hand of the clinician and to maintain positioningof the instrument, especially with respect to the sensitive dentateline; 3) simplification of the system to better ensure consistentclinical results so the procedure is not dependent on the skills of theclinician and that the system is available to a wider range ofclinicians to utilize; and 4) minimization of instrumentation utilizedfor treatment of hemorrhoids. It should be appreciated that having suchimprovements reduces the technical complexity and increases the efficacyand safety of otherwise more complex hemorrhoid tissue treatmentprocedures.

It should be appreciated that the present invention provides ananoscope, a ligating device and/or a system comprising an anoscope and aligating device. However, it is also contemplated that a differentligating device or other instrumentation can be used with the anoscopeof the present invention, i.e., inserted through the dedicated channelof the anoscope. It is also contemplated that the ligating device(ligator) of the present invention can be used with anoscopes other thanthose of the present invention disclosed herein. Thus, variousembodiments of the anoscopes of the present invention will be discussedinitially, followed by a discussion of the ligation instrument of thepresent invention and then followed by a description of the method ofuse.

Turning first to the anoscope, several embodiments of the anoscope aredisclosed herein. The commonality of the anoscopes is the feature of achannel angled with respect to the longitudinal axis of the main channelof the anoscope. The channels can be of various lengths, of variousconfigurations and can have slots at various locations. These differentembodiments are discussed in detail below.

With regard to the anoscopes and ligating devices disclosed herein, theproximal portion is considered the portion or region closer to the userand the distal portion is considered the portion or region further fromthe user. However, when referring to the anatomy, e.g., the anal canaland the hemorrhoidal tissue, the proximal portion is the portion orregion closer to the head or heart of the patient and the distal portionis the portion or region further from the head or heart of the patient.Thus, when discussing the anatomy, the distal end of the ligating deviceis placed proximal (further inwardly or “above”) the dentate line of thepatient. To help understanding, as used herein when referring to theanatomy, “anatomically distally/anatomically proximally” will be used todifferentiate from distal/proximal of the instruments and anoscopes.

Referring now in detail to the drawings wherein like reference numeralsidentify similar or like components, FIG. 1 illustrates one embodimentof the anoscope (also referred to as a cannula) of the presentinvention, shown in cross-section in FIG. 3A. The anoscope is designatedgenerally by reference numeral 10 and includes a proximal portion 12 anda distal portion 14, the wall of the anoscope tapering toward the distalportion 14.

A proximal flange 16 of anoscope 10 provides a wider rim that preventsinsertion of anoscope 10 fully into the anal canal and facilitatesgripping by the clinician. The anoscope 10 includes a window 18 at thedistal portion 14, the window 18 providing access to the targethemorrhoid tissue for the ligating device extending through the anoscopeas described below. As shown, the distal end of anoscope 10 has a distaledge 20 and a distal edge 22 on opposing sides of a longitudinal axis ofthe anoscope, the distal edge 20 spaced axially proximally of the distaledge 22. Stated another way, the distal portion 14 of the anoscope 10 isangled so that a distal edge 20 of the wall 31 adjacent the window 18 isproximal of the distal edge 22 of the wall 33 opposite the window 18.The distal end has a curved contour as shown.

The anoscope 10 has a channel (also referred to herein as a lumen) 26dimensioned and configured to receive an obturator such as obturator 70of FIG. 3A. The channel 26 extends along a longitudinal axis of theanoscope 10 and can be considered the main channel (lumen) of theanoscope. In the illustrated embodiment, channel 26 has a transversecross-section varying in diameter and shape along its length, however,different shaped channels and different shaped cross-sections, e.g.,circular, oval, asymmetric, etc. are contemplated and can be uniform orchange (non-uniform) along the length. Anoscope 10 also includes anangled channel (also referred to herein as a lumen) 28. Channel 28 formsan internal channel for receiving an instrument (device), i.e., forinsertion of the ligating device described below or other hemorrhoidtreatment devices, and is therefore also referred to herein asinstrument channel. In the illustrated embodiment, channel 28 iscylindrical with a circular transverse cross-section, however, differentshaped channels and different shaped cross-sections, e.g., oval, arealso contemplated. Instrument channel 28 is preferably smaller indiameter than main channel 26. It is also preferably shorter in length.

As shown in FIG. 3A, channel 28 forms an acute angle with channel 26 andhas a proximal opening 30 and a distal opening 32, the distal opening 32communicating with channel 26 as it opens into channel 26 as shown forexample in FIGS. 3A and 4. That is, channel 28 intersects channel 26 soan instrument inserted through channel 28 can extend into channel 26 towindow 18 to access tissue through window 18. As discussed above andshown in the cross sectional views, wall 33 of anoscope 10 terminates atedge 22 distally of window 18 and opposing internal wall 31 terminatesat edge 20 proximally of inner wall 33. Internal wall 35 of channel 28terminates at edge 35 a, preferably in an intermediate region of theanoscope 10.

The internal wall of the instrument channel can be continuous along itslength as shown in the alternate embodiment of FIGS. 2C and 3C. In thisembodiment, a solid wall 44 forms the perimeter (circumference) of theinstrument channel 42 of anoscope 40. The channel 42 can be of circulartransverse cross-section, however, different shaped channels anddifferent shaped cross-sections, e.g., oval, are also contemplated. Theanoscope 40 is otherwise identical to anoscope 10 and therefore forbrevity will not be discussed in further detail since the structure andfunction of anoscope 10 is fully applicable to anoscope 40, i.e., theflange 45, main channel 46, window 48, etc.

Returning to the embodiment shown in FIGS. 1 and 3A, the internal wall35 of channel 28, i.e., the wall facing the longitudinal axis of thechannel 26, is a broken wall wherein the internal wall 35 has one ormore gaps or fenestrations (openings) 37. This can be formed by forminggaps or openings in one or more regions of the wall 35, extendingradially around a partial circumference of the wall of the channel 28.Alternatively, two or more shorter discrete channels can be provided,spaced apart axially, thereby providing an instrument channel with anon-continuous wall due to the space between the separated channels.Thus, instead of one or more partial circumferential fenestrations alonga length, a full 360 degree gap(s) can be provided. This non-continuouswall (formed by fenestrations or separated channels), if utilizedinstead of a continuous wall, has the advantage of providing arelatively longer channel while reducing the amount of material ascompared to if a long continuous channel wall is utilized. It could alsosimplify manufacture. Additionally, the gaps/openings in the wall enablethe clinician to visualize the passage of the instrument through theinstrument channel 28 as the clinician looks through the main channel 26of the anoscope 10.

In the illustrated embodiment, the proximal opening 30 of channel 28 iswithin channel 26, just distal of flange 16, however, in alternateembodiments, the proximal opening 30 can be, i.e., the angled channel 28can begin, within the flange 16 so it is more proximal than that shownin FIG. 3A or can begin at the proximal opening of the flange 16.Alternatively, the angled channel 28 can have a proximal opening distalof the position of FIG. 3A, e.g., distal of the distal end of the regionof the flange 16. The angled inner wall 35 of the channel 28 preferablyterminates in a mid region of the anoscope, leaving enough space so asnot to interfere with insertion of obturator 70 as shown in FIG. 3A norinterfere with the clinician's naked eye viewing through channel 28.Note the wall 35 forming the wall of channel 28 can be of differentlengths than that shown as long as it is of sufficient length to supportan instrument and not excessive length so as to interfere with theobturator or obstruct the clinician's view through channel 26 of theanoscope. As mentioned above, the internal wall 35 can be a solid wallor alternatively can be a fully broken wall or a wall withfenestrations. Also note that the wall of the instrument channel 28 canbe formed in part by the wall of the anoscope so that channel 28 andanoscope 10 share a common wall.

In the embodiment of FIG. 1, the outer wall 33 angles to intermediateregion, i.e., angles inwardly toward the longitudinal axis of theanoscope, and then has a reduced angle toward the distal end while theopposing wall 31 (the wall of the window 18) is substantially linear,i.e., substantially aligned with the longitudinal axis. Alternatively,wall 31 can also be angled, e.g., angled inwardly toward thelongitudinal axis. Tapers other than those illustrated are alsocontemplated.

FIGS. 2A and 2B illustrate alternate embodiments of the instrumentchannel of the anoscope of the present invention. Except for theinstrument channels, the anoscope of FIG. 2A and FIG. 2B are identicalto anoscope 10 of FIG. 1. Therefore the discussion of the anoscope(other than the instrument channels) is not repeated herein and only theinstrument channels are discussed in detail since the other features andfunctions of anoscope 10, e.g., the flange, main channel, window, etc.,are fully applicable to the anoscopes of FIGS. 2A and 2B.

In FIG. 2A, the anoscope 50 has a proximal flange 52, a main channel 53to removably receive an obturator, e.g., obturator 70, and an internalinstrument channel 54. Instrument channel 54 has a partial wall segmentas it opens inferiorly along its length. That is, channel 54 has alongitudinally extending elongated opening 56 extending along itslength, with the elongated opening 56 facing the main channel 53 of theanoscope 50. Stated another way, the channel 54 is C or U-shaped as thecircumference of its wall extends for less than 360 degrees. Channel 54has a proximal opening 55 and a distal opening 57 (see FIG. 3D showing across-sectional view of the anoscope of FIG. 2A). As illustrated, thechannel 54 is relatively short, extending for a minimal distance withinthe anoscope and terminating at distal end 51 a short distance from theflange 52. However, it should be appreciated that the channel 54 can beof a longer length such as the length of channel 28 of FIG. 3A.

The longitudinal opening 56 enables an instrument, e.g., a ligatinginstrument, to be loaded laterally into the channel 54. Such lateralloading is shown for example in FIGS. 16 and 17. This lateral insertioncan be advantageous for example if the instrument is dimensioned so thatit has regions of varying diameter which could not fit through proximalopening 55. In other words, if an instrument, such as a ligatinginstrument, has for example a distal region which has a diameter greaterthan a diameter of the channel 54, e.g., the diameter of the proximalopening 55, the instrument could not be inserted longitudinally throughthe opening 55 because it would not fit. However, it could be loadedinto the channel 54 by inserting a smaller diameter portion laterallythrough the longitudinal opening 56 as shown. Clearly, if theinstruments are of a small enough dimension, rather than lateralinsertion, if desired, they can alternatively be inserted into thechannel 54 through proximal opening 55 such as shown in FIG. 18. Thus,channel 54 allows for both proximal (longitudinal) and lateral insertionof the instrument therein, which can be dependent on the size of theinstrument utilized. Additionally, it in certain embodiments, thechannel 54 can be made of a material that is flexible so that theinstrument could have a slightly larger diameter which flexes thechannel 54 (walls of the channel) as it is inserted laterally therein.That is, the wall 58 of the instrument channel can be composed of amaterial that provides sufficient flexibility to expand when theinstrument is inserted laterally (and also longitudinally). This wouldenable larger instruments to be laterally inserted therein as theinstrument would flex the wall of the channel 54 to widen thelongitudinal opening 56 for insertion, and then after insertion the wallwould flex back toward a more closed position. Sufficient flexibilitycould also allow a larger diameter instrument to be insertedlongitudinally since the elongated opening increases the flexibility ofthe instrument channel.

The shorter channel if utilized provides the advantages enumerated aboveof less material and improved visualization of the instrument by theclinician as it is being inserted through the channel 54 since minimalpart of the instrument is blocked by the wall of the channel.

Note in FIGS. 16 and 17 (and 18) the instrument is shown schematicallyand labeled as instrument A as various types and sizes of instruments,including the ligating instrument of the present disclosure, can beutilized with the anoscope 10

An alternate embodiment of the instrument channel is illustrated in FIG.2B. In this embodiment, the internal instrument channel 64 of anoscope60 has an opening 65 along its length which rather than facinginferiorly, faces in another lateral direction. Anoscope 60, likeanoscope 10, has a proximal flange 62 and a main channel 63 to removablyreceive an obturator, e.g., obturator 70. Instrument channel 64 has apartial wall segment as it opens along its length, facing away from thelongitudinal axis of anoscope 60 and toward wall 61 of anoscope 60. Thechannel 64 is C or U-shaped as the circumference of its wall extends forless than 360 degrees. Channel 64 has a proximal opening 65 and a distalopening. As illustrated, the channel 64 is longer than channel 54 as itextends further into the anoscope 10, for example a distance of theinstrument channel of FIG. 3C. Alternatively, it could be relativelyshort, extending for a minimal distance within the anoscope andterminating at a distal end a short distance from the flange 62 in thesame manner as channel 54 of anoscope 50 of FIGS. 2A and 3D. In eitherlength, the elongated longitudinally extending opening 65 enables aninstrument, e.g., a ligating instrument, to be loaded laterally into thechannel 64 as in the lateral loading shown in FIGS. 16 and 17, however,the approach to the channel 64 would be different since the longitudinalopening is at a different region than the opening 56 in channel 54.Loading longitudinally through the proximal opening 65 as in FIG. 18 isalso contemplated if the instrument size permits. The lateral insertioncan be advantageous for the reasons described above. Advantages of ashorter channel are also described above. However, it should beappreciated that the longer channel has the advantage of improvedstability of the instrument positioned therein because the instrument isretained along a longer length. As with channel 54, in certainembodiments, the channel 64 can be made of a material that is flexibleso that the instrument could have a slightly larger diameter whichflexes the channel 64 as it is inserted laterally therein or even ifinserted longitudinally through the proximal opening 65, and then afterinsertion the wall would flex back toward a more closed position.

FIGS. 2A and 2B show examples of positioning of the longitudinal openingwith respect to the main channel of the endoscope. It should beappreciated, that the openings could be located in other positions.Also, the openings can be of larger or smaller size. For example, thechannel can have an opening in the form of a narrow slit extending alongits length.

Thus, the asymmetric anoscope 10 of the present invention, in theembodiments described herein, has a dedicated channel on the wallopposite to the target tissue to receive an instrument (device) such asthe rubber band ligator (also referred to herein as an elastic bandligator) to form a guide section. The channel can be in the shape of acylinder (or alternatively other configurations), which can have aseparate wall or share the wall with the anoscope and/or have acontinuous or non-continuous, e.g., a fenestrated wall. A single channelforming the guide section can be provided or alternatively two or moreaxial spaced channels can provide guiding sections for the instrument,e.g., the ligator, through the anoscope. The channel can also have alongitudinal slot or opening along its length, providing across-sectional configuration of a C or U shape.

The anoscope of any of the embodiments disclosed herein can include avisual marker such as red marker on the exterior and/or interior sidewall of the anoscope by the treatment window, although othermarkers/indicators are also contemplated. Such marker is shown forexample in FIG. 3B and designated by reference numeral 17. The marker 17is located between walls 33 and 31 and the distal edges 22 and 20. Themarker aids the positioning of the anoscope relative to the dentateline. That is, the anoscopes disclosed herein are positioned so that thedentate line of the patient is visible just anatomically proximal to theproximal edge of the treatment window of the anoscope—the target pointfor tissue ligation. Therefore, the anoscope is positioned so the marker17 is aligned with the target tissue and approximately 2 cm from thedentate line. This means the anoscope is inserted so the marker 17 isapproximately 7 cm from the anal orifice.

The anoscope of any of the embodiments disclosed herein can include astructure to engage, e.g., interlock, with the ligating instrument torestrict movement of the ligating instrument with respect to theanoscope. Such structure, which is also referred to herein as a lockingstructure, interlocking structure or a blocking structure, is shown inFIGS. 5, 6 and 7. Anoscope 50 is illustrated by way of example toillustrate the locking structure, it being understood that the otheranoscopes disclosed herein can also have this locking structure. Asshown in FIG. 5, anoscope 10 has a slot 58 formed in its wall, the slot58 having an axial region 58 a and a radial region 58 b, forming anL-shape, the radial region being a more distal region. The slot 58 canbe located at a proximal end of the anoscope 50, e.g., just distal ofthe flange 52 as shown by the designated area of detail of FIG. 4.Alternatively, it can be located at other regions of the anoscope, e.g.,further distal than the location of FIG. 4.

Slot 58 has a distal wall 59 a at the distal end of axial region 58 athat forms a distal stop for the ligating instrument. Radial region 58 bhas a proximal wall 59 b forming a proximal stop for the ligatinginstrument. Radial region 58 b shares the distal wall 59 a. The distalstop restricts distal movement of the ligating instrument within theanoscope and the proximal stop restricts proximal movement of theligating instrument within the anoscope. The ligating instrument 80 hasengagement structure 83 extending from an outer surface 81 of its outerwall which can be in the form of a hook-like engagement member. When theligating instrument 80 is initially inserted into channel 54 of anoscope50, engagement structure 83 is received in the narrower axial slotregion 58 a and the ligating instrument 80 cannot rotate in eitherdirection as it is blocked by side walls 59 c and 59 d of slot region 58a. When the ligating instrument 80 is advanced, its engagement structure83 contacts distal wall 59 a. Thus, distal wall 59 a restricts (blocks)further distal movement of the ligating instrument 80. At this pointwhen the distal stop surface (wall 59 a) is engaged by engagementstructure 83 of ligating instrument 80, the engagement structure 83 ofthe ligating instrument 80 is aligned with the radial slot region 58 bas shown in FIG. 6. This slot region 58 b provides room for the ligatinginstrument 80 to be rotated in the direction of the arrow of FIG. 6 tothe position of FIG. 7. In this position of FIG. 7, the ligatinginstrument 80 still cannot be advanced distally due to wall 59 a andfurther cannot be retracted proximally due to proximal wall 59 b. Thus,the distal and proximal walls of the engagement structure 83 abut therespective distal and proximal walls 59 a, 59 b to prevent axialmovement in either direction. This maintains the ligating instrument 80in its axial position during the procedure, ensuring that its positionwith respect to the dentate line (and marker on the anoscope ifprovided) is maintained during the surgical procedure. Note that toremove the instrument after the procedure, the ligating instrument 80 isrotated in the opposite direction of the arrow of FIG. 6 to re-align theengagement structure 83 of the ligating instrument 80 with the axialslot region 58 a so it can be withdrawn proximally along the region 58a.

Thus, the anoscope 50 has a channel or slot to receive a raised portion(raised engagement or locking structure) of the ligating instrument,with the channel having a first configuration and a second differentconfiguration. The first configuration restricts rotation of theligating device within the anoscope during its insertion distally andthe second configuration allows slight rotation of the ligating deviceto enable engagement of the proximal stop to interlock the ligatinginstrument and anoscope to restrict proximal and distal axial movementof the ligating instrument within the instrument channel. Thus, theligating device is first stopped by the stopping feature andsubsequently locked by the device's locking feature so the tip of theligating instrument 80 is placed and fixated at the target tissue (crossof the line corresponding to the device marker and a line correspondingto the middle of the lower wall of the anoscope). Although describedabove for locking ligating instrument 80, other instruments can beprovided with the engagement structure to provide for locking to theanoscope in the manner described herein.

Note during insertion through the axial slot region 58 a, as notedabove, the ligating instrument cannot be rotated. However, when in theradial slot region 58 b, it can be rotated back into alignment with slotregion 58 a. To limit rotation during the procedure when it is engagedwith the radial region 58 b, the proximal wall 59 b and/or the distalwall 59 a in the region of slot region 58 b can be provided with one ormore detents or other structure so that a predetermined force isrequired to rotate the ligating instrument and engagement structure fromthe position of FIG. 7 back to the position of FIG. 6. In this manner,rotational movement of the ligating instrument can be restricted unlessthe clinician rotates the ligating instrument with a sufficient force tooverride the detent(s) to align with axial slot region 58 a. With thisprovision, the ligating instrument would be locked (blocked) from axialand rotational movement during use.

It should also be appreciated that due to the engagement structure/slotarrangement in this embodiment, the ligating instrument can only beinserted in an orientation where the engagement structure is alignedwith the slot. If not aligned, the instrument will not fit within thechannel. To facilitate such orientation, one or more markers can beprovided on the anoscope to aid alignment of the ligating instrumentwith the slotted region of the anoscope.

FIGS. 5-7 shown the slot regions 58 a, 58 b formed in the anoscope 50 ofFIG. 3A. By way of another example, FIG. 8A shows such slotted regionsused with the anoscope 40 of FIG. 2C having a closed channel 42. Theslot regions 48 a, 48 b of FIG. 8A are identical to the slot regions 58a, 58 b, respectively, of FIGS. 5-7 and therefore further discussion isnot warranted since the interaction of the ligating instrument 80 withthe slot regions 58 a, 58 b and distal and proximal walls 59 a, 59 b isfully applicable to the slot regions 48 a, 48 b and distal and proximalwalls 49 a, 49 b of anoscope 40. The interaction with anoscope 40 isshown to illustrate by way of example that the interlocking structurecan be utilized with any of the instrument channels disclosed herein.

FIGS. 5-8A illustrate one type of stop and locking mechanism. It is alsocontemplated that other mechanisms can be provided to restrict distaladvancement of the instrument through the channel of the anoscope and/orlock axial movement in both proximal and distal directions and/orrestrict rotation of the instrument with respect to the anoscope.

Turning now to the rubber (elastic) band ligation device (also referredto herein as the ligator or ligating device or ligating instrument) ofthe present invention, and with initial reference to FIG. 9 which showsthe ligating device already inserted through the anoscope, ligatingdevice (instrument) 80 has a distal portion 82 for positioning withinthe body of the patient and a proximal portion 84 extending outside thebody for manipulation by the operator (clinician). Ligating device 80includes an inner or middle tube-like structure 86 with a lumen(channel) 88, a plunger 90 slidable within lumen 88 of inner tube 86 andan outer tube 92 with a lumen (channel) to receive the inner tube 86.The inner and outer tubes 86, 92 are relatively movable. The plunger 90and inner tube 86 are also relatively movable. An elastic (rubber) band94 is carried, e.g., supported in tension, by the inner tube 86 and ispositioned on an exterior wall 88 a of the inner tube 86 for deploymenttherefrom by distal advancement of the outer tube 92 which pushes theelastic band 94 off wall 88 a. The inner tube 86 has a distal end 87 andproximal end 89. The distal end is 87 substantially round or oval,although other configurations are contemplated, and engages the targettissue to work with the plunger 90 for suctioning tissue. The proximalend 89 extends proximally of the anoscope. The wall of inner tube 86 andouter tube 92 may be whole or incomplete, e.g., have fenestrations, toreduce the amount of material and to enable viewing of the plunger 90sliding within the lumen 88 of the inner tube 86.

The proximal end 89 of the inner tube 86 can extend proximally of theouter tube 92 or the proximal end alternatively can terminate distallyof the proximal end of the outer tube 92. The inner tube 86 can containthe projecting engagement structure 83 which releasably engages thestopping and locking features at a proximal end of the anoscope. Aportion of the outer tube 92 can be cut away to expose the engagementstructure 83 of inner tube 86 so that the engagement structure 83 caninteract with the slotted regions (e.g., regions 58 a, 58 b) of theanoscope to provide the aforedescribed axial and rotationalrestrictions. The outer tube 92 can alternatively have a circumferenceof less than 360 degrees, e.g., be C or U-shaped along its length, orpartial length, to expose the engagement structure 83 or engagement withthe slotted regions 58 a and 58 b. FIG. 8B illustrates by way of examplean embodiment of the outer tube 92′ having a window or cutout 93 formedtherein aligned with the engagement structure 83 of inner tube 86. Thewindow 93 exposes the engagement structure 83. The window 93 allows forsufficient longitudinal (axial) movement of the outer tube 92′ withrespect to the inner tube 86 to dislodge a rubber band from the ligatinginstrument 80. The outer tube 92′ with window 93 can be utilized withany of the embodiments of the ligating instrument and anoscope disclosedherein and is shown in conjunction with the anoscope 40 of FIG. 8A byway of example.

Note in alternate embodiments, the projecting engagement structure canbe located on the outer tube 92 and the inner tube 86 and outer tube 92would be interlocked so that stopping and locking of the outer tube 92to prevent axial and/or rotational movement, would likewise result instopping and locking the inner tube 86 as well.

Referring back to FIG. 9, the plunger 90 includes a proximal handle 96for gripping by the user, an elongated rod 97 extending distally fromthe handle 96, and a transversely (horizontally) extending plate 98connected at the distal end of rod 97. The handle 96 extends proximallyof the inner tube 86 and outside the patient for access by theclinician. The rod 97 can be connected to an upper (proximal) surface ofthe plate 98, and can in some embodiments be connected to a centralregion of the plate 98. The plate 98 can be round, oval or otherconfigurations. The plunger 90 provides for suctioning of the tissueinto the inner tube 86 for subsequent application of the elastic band.

One of the main technical challenges for an operator during the rubberband ligation technique is related to the need, while holding theanoscope, to pull on the target tissue and when “just the right amount”of the target tissue appears to be engaged, to release the rubber bandonto the base of the pulled tissue. These maneuvers require coordinatedmanipulations of both hands of the operator and possibly an assistantholding the anoscope. In addition, the view of the target area can beobscured by the instruments and the operator's own hands, furtherchallenging the procedure. Also, the amount of the suctioned tissue mayneed to vary from case to case and in certain instances, e.g., if morethan the desired amount of tissue is suctioned into the inner tube, theneed might exist to “slightly release” the suctioned tissue.

The plunger 90 slides within the inner (middle) tube-like structure 86.The plate 98 of the plunger 90 is positioned distally of the inner tube86. Such distal positioning can be achieved during use or alternatively,the instrument can be provided so that the plate 98 is always locateddistally, i.e., during packaging, initial insertion and use.

The plunger 90 is actuated by the operator's hand for the purpose ofcreating and gauging the suction on the target tissue. By moving theplunger 90 forward (distally) towards the target tissue, the tissue canbe engaged. By moving the plunger backward (proximally) while the distalend of the inner (middle) tube 86 is hermetically pressed against thetarget area, the target tissue is suctioned into the distal end (thetarget tissue chamber) of the inner tube 86. The inner tube 86 thusforms a target tissue chamber within its lumen 88 for receipt of thesuctioned tissue. If excess tissue is suctioned into the inner tube 86,the clinician can re-advance the plunger 90 as in FIG. 11 to release thesuction and thereby release some of the tissue. Thus, such distalmovement enables the user to release a portion of the suctioned tissueor, if desired, release the entire suctioned tissue from the tissuechamber formed in the inner tube 86.

FIG. 19 illustrates an alternate embodiment of the ligating device ofthe present invention. The ligating device 80′ is identical to ligatingdevice 80 of FIG. 9 except that it has a bent distal tip 80 a. The benttip 80 a is bent toward the target tissue and in certain applicationsmight facilitate tissue engagement and might improve access andvisibility of the target tissue. Device 80′ is otherwise identical todevice 80 so for brevity is not further discussed since the structureand function of device 80 are fully applicable to device 80′. For easeof understanding, the like (corresponding) components of device 80′ havebeen designated with prime reference numerals, e.g., plunger 90′, plate98′, inner tube 86′, outer tube 92′. As with the device 80, device 80′can include a mechanism (actuator) to advance the inner tube or theinner tube can be accessible to the user at a proximal end extendingproximally of the outer tube or through an opening in the outer tubethat enables access to the inner tube.

The use of the anoscope and ligating device of the present inventionwill now be described, in conjunction with FIGS. 3A, 9-15 and the flowchart of FIG. 20. Note the discussion of the method of use is describedwith the use of anoscope 10, it being understood that the anoscope ofthe other embodiments disclosed herein could be utilized and wouldoperate in a similar fashion, except for the possible lateral insertionof the ligating instrument into the instrument channel as describedabove rather than the longitudinal insertion. The ligating devicedescribed and illustrated in these Figures is the aforedescribedligating device 80.

In the first step, the blunt tip obturator 70 is inserted longitudinallyinto the main channel 26 of the anoscope (cannula) 10 and then theanoscope (cannula) 10 with the blunt tip obturator 70 positioned thereinand extending slightly distally of the anoscope 10 are introduced intothe rectum of the patient, inserted approximately 7 cm into the rectum(see FIG. 3A). The obturator 70 is then removed from the anoscope andthe internal hemorrhoid and dentate line are visualized through theproximal opening and channel 26 of the anoscope 10. The anoscope 10 ispositioned so the marker 17 is spaced a predetermined distance from thedentate line, e.g., 2 cm anatomically proximal of the dentate line.Thus, in the illustrated embodiment, the edge 20 adjacent the window 18of can be positioned at the dentate line (or just proximal of thedentate line) since the marker 17 is positioned 2 cm from the edge 20.

Next, with the position of the anoscope 10 satisfactory (via directvisualization), the ligating device (ligator) 80 is inserted into theangled channel (lumen) 28 of the anoscope (FIGS. 3B and 9) and movedforward towards the marker 17 which provides the identification of thetarget area. Lateral movement of the ligating device 80 is restricted bywall of the channel 28. The ligating device 80 is advanced until stoppedby the device-stopping feature of FIGS. 5-7 as the projecting engagementstructure 83 of the ligating device 80 contacts the distal wall 59 a ofthe slot 58 a of the anoscope 10. Note the ligating device 80 is alignedwith the channel 28 so that its engagement surface 83 is aligned withslotted region 58 a so it can slide within the channel 28. Note theligating device 80 can be inserted into the channel 28 eitherlongitudinally as in FIG. 18 or laterally as in FIG. 17. When inabutment with the stop (distal wall 59 a), the tip of the device 80 isin the desired position with respect to the target hemorrhoid tissue Tand the dentate line (FIG. 9). After contacting the distal stop, i.e.,distal wall 59 a, the ligating device 80 is rotated (FIGS. 6-7) so theengagement structure 83 moves into radial slot 58 b, thereby locking theligating device 80 as proximal and distal axial movement are restrained.In this locked position, the distal end of the ligating device 80 isengaged with the hemorrhoid tissue anatomically proximal of thepatient's dentate line, thereby ensuring the elastic band is not placedtoo close to the dentate line which can lead to undesirable sideeffects/complications such as severe pain, tenesmus, fainting, rectalperforation, infection, and/or severe bleeding. With the ligating device80 fixed to the anoscope 10, the operator visually confirms the desiredtarget position.

Once confirmed, the plunger 90 inside the hollow internal tube 86 isthen slowly pulled back as the end of the inner tube 86 presses andseals against the tissue as shown in FIG. 10, thereby suctioning thetarget tissue into the lumen 88 of the inner tube 86 under directvisualization and assuring that the patient is not experiencing anydiscomfort. After the desired amount of the target tissue is suctionedinto the distal chamber within the lumen 88, the elastic band 94 isready to be applied. However, prior to elastic band application, if theoperator determines that too much tissue has been suctioned into thechamber of the internal tube 88, the plunger 90 can be advanced distallyas shown in FIG. 11 to release some of the tissue. Note that if it isdesired to fully release the tissue to then re-suction the tissue fromthe beginning, the plunger 90 can be pushed distally to its originalposition, thereby entirely releasing the suction. Also note that if theoperator is satisfied with the amount of tissue suctioned into thechamber of the inner tube 86, then the step of FIG. 11 is omitted andthe operator proceeds to the elastic rubber band application as in FIG.12. This is illustrated in the flow chart of FIG. 20 at the decision boxinquiring whether excessive tissue has been suctioned.

Once the clinician is satisfied with the tissue suctioned within theinner tube 86, the outer tube (advancer) 92 is advanced distally in thedirection of the arrow of FIG. 12 (as the inner tube 86 remains fixed)to push the elastic rubber band 94 as its distal end contacts (abuts)the elastic rubber band 94 supported on the exterior surface of theinner tube 86. The outer tube 92 is pushed forward until the elasticband 94 is pushed off (dislodged from) the inner tube 86. The elasticband 94 is thereby released onto the base of the suctioned tissue asshown in FIG. 13 to strangulate the target tissue.

The ligating device 80 is then withdrawn proximally in the direction ofthe arrow of FIG. 14 for removal from the anoscope. After removal of theligating device 80, the anoscope is then withdrawn proximally from therectum in the direction of the arrow of FIG. 15.

If it is desired to treat another hemorrhoid, and the device 10 carriesmultiple elastic bands, the anoscope 10 and ligating device 80 arerotated to align the window of the anoscope with the target hemorrhoidtissue, the location of the anoscope 10 and ligating device 80visualized with respect to the dentate line. Then the plunger 90 isretracted to suction the tissue into the lumen 88 of inner tube 86followed by advancement of the outer tube 92 to release another elasticband 94 in accordance with the steps of the procedure illustrated inFIGS. 10-13 and depicted in the flow chart where if an additionalhemorrhoid needs to be treated, it loops back to the procedure as shown.If it is desired to treat another hemorrhoid and the ligating device 10carries only a single elastic band 94, the ligating device 80, with theanoscope 10 remaining in position, is withdrawn and another elastic band94 is loaded onto the exterior surface of the inner tube 86 (The outertube 92 can be retracted to leave a portion of the exterior surfaceexposed to provide room for mounting the elastic band 94). The ligatingdevice 10 with the newly mounted elastic band 94 is then insertedthorough the anoscope 10, the tissue suctioned and the outer tube 92advanced in the manner described above in conjunction with FIG. 9-13.The procedure can be repeated until all other internal hemorrhoids(typically a total of three) are treated.

FIG. 21-22B illustrate alternate embodiments of the anoscope utilizingthe angle of the second channel itself to ensure positioning of theligating or other instrument anatomically proximal of the dentate line.More specifically, anoscope 100 of FIG. 21 has a proximal portion 102and a distal portion 104, the wall of the anoscope tapering toward thedistal portion 104. The anoscope 100 terminates at distal edge 105 anddistal opening 106. The anoscope 100 has a channel (lumen) 108dimensioned and configured to receive an obturator such as obturator 70of FIG. 3A. The channel 108, like channel 26 of anoscope 10 discussedabove, extends along a longitudinal axis of the anoscope 100. In theillustrated embodiment, the channel 108 has a transverse cross-sectionvarying in diameter and shape along its length, however, differentshaped channels and different shaped cross-sections, e.g., circular,oval, asymmetric, etc. are contemplated and can uniform or change(non-uniform) along the length.

Angled internal instrument channel (lumen) 110 forms a channel forreceiving an instrument (device), e.g., the ligating device describedherein. Channel 110 is cylindrical with a circular transversecross-section, however, different shaped channels and different shapedcross-sections, e.g., oval, are also contemplated. Instrument channel110 is preferably smaller in diameter than main channel 108. Channel 110forms an acute angle with channel 108 and has a proximal opening 113 anda distal opening 112 terminating adjacent distal opening 106 of channel108.

The walls of the anoscope 100 are configured and angled so that in usethe target tissue (represented schematically by “X”) is at a vertex ofthe triangle formed by the side of the anoscope. That is, the vertex Vof the triangle is formed at the intersection of a) an imaginary line Lextending (extrapolated) from the edge 107 (along the longitudinal axisof the edge) of anoscope 100 and b) the longitudinal axis of the angledchannel 110 extended (extrapolated) distal of the distal edge 105(imaginary line M). Thus, with the walls angled in such a way, thevertex V of the triangle where the target tissue is located ispredictably located a fixed distance, e.g., about 2 cm to about 2.5 cm,proximal to the dentate line (represented by “D”) of the patient whichis positioned to be visible near the edge 105 of the anoscope 100.Therefore, a marker need not be utilized since in use, the clinicianwould insert the anoscope until the distal edge 105 is at the visualizeddentate line (visualized with the naked eye as the clinician looksthrough channel 108). In this position, when an instrument is insertedthrough the angled (second) channel 110, the tip of the instrument whencontacting the target tissue would be about 2 cm to about 2.5 cmanatomically proximal from the dentate line (the distance from V to D).The instrument could be locked to the anoscope in this positionutilizing the interlocking structure discussed above.

The anoscope 120 of FIG. 22A is identical to the anoscope 100 of FIG. 21except that angled instrument channel 124 has a slanted or angled distaltip 126 at edge 128. That is, edge 128 angles proximally to increasevisibility by limiting the blocking of the view through the main channel(lumen) 122. In all other respects, anoscope 120 is identical toanoscope 100 so further discussion is not warranted as the features anduse of anoscope 100 described herein are fully applicable to anoscope120. The line L (extrapolated from edge 125) and vertex V are also shownin FIG. 22A to illustrate the predictable positioning of theinstrumentation anatomically proximal of the dentate line (the distancefrom dentate line D to vertex V formed at the intersection of imaginaryextrapolated lines L and M which in preferred embodiments is betweenabout 2 cm to about 2.5 cm). FIG. 22B shows a ligating instrument, e.g.,ligating instrument 80, inserted through the anoscope 120 to illustratethe distal tip 81 of instrument 80 at the vertex V of the imaginarytriangle. Both anoscopes 100 and 120 can include a flange as illustratedas in the other embodiments described herein.

Note the channels 110 and 124 can open partially or fully outside/distalto the anoscope 100. Also, as an alternative to the continuous channelshown, channel 110 or 124 can be non-continuous, have an elongated slotso it is U or C-shaped, etc. as in the various embodiments of thechannels discussed above and illustrated in the drawings. Thus, thesevariations of the angled instrument channel discussed above areapplicable to channels 110 and 124 of the anoscope 100 and 120,respectively.

While the above description contains many specifics, those specificsshould not be construed as limitations on the scope of the disclosure,but merely as exemplifications of preferred embodiments thereof. Forexample, those skilled in the art will envision many other possiblevariations that are within the scope and spirit of the disclosure asdefined by the claims appended hereto.

What is claimed is:
 1. An anoscope having an outer wall dimensioned andconfigured for insertion into the anal canal, the anoscope having aproximal end, a distal end, a first channel, and a second channelintegral with the anoscope, the first channel extending longitudinallythrough the anoscope, the first channel having a proximal opening and adistal opening, the second channel positioned at an angle to alongitudinal axis of the first channel, the second channel having aproximal opening and a distal opening, the second channel including awall within the first channel, the distal opening of the second channelcommunicating with the first channel, the second channel dimensioned andconfigured to receive a ligation device, wherein the wall of the secondchannel is longitudinally shared with the first channel.
 2. The anoscopeof claim 1, further comprising a stop to limit distal movement of theligation device inserted through the second channel.
 3. The anoscope ofclaim 2, further comprising a stop on the anoscope to limit one or bothof proximal movement or rotational movement of the ligation devicepositioned in the second channel.
 4. The anoscope of claim 1, whereinthe second channel is on a first side of the anoscope, and the distalend of the anoscope forms a window on a second side of the anoscope,wherein a distal end of the first side is distal of an opposing end ofthe anoscope on the second side.
 5. The anoscope of claim 1, wherein thewall of the second channel includes a plurality of fenestrations toprovide spaced discrete longitudinally aligned channels.
 6. The anoscopeof claim 1, wherein the second channel includes a longitudinallyextending slot to enable lateral insertion of the ligation device intothe second channel.
 7. The anoscope of claim 1, wherein the anoscope hasa marker to indicate a distance from a dentate line of a patient.
 8. Theanoscope of claim 1, wherein the first channel has a longitudinal axisand the anoscope stabilizes the ligation device during a hemorrhoidtreatment procedure and the first channel provides direct visualizationto a clinician through a length of the first channel and the secondchannel directs the ligation device inserted through the second channelat an angle to the longitudinal axis of the first channel to reduceobstruction of direct visualization through the first channel.
 9. Asystem for treatment of hemorrhoids comprising: an anoscope having alongitudinal axis and a first channel extending along the longitudinalaxis of the anoscope and a second channel integral with the anoscope andpositioned at an angle to the first channel, the second channel having awall extending within the first channel and intersecting the firstchannel, wherein a distal opening of the second channel is incommunication with the first channel; and an elastic band ligationdevice insertable into the second channel, the elastic band ligationdevice including a first tube and a tissue holder, the first tubemovable to advance and dislodge an elastic band from the elastic bandligation device onto a target tissue, the second channel stabilizing theelastic band ligation device and restricting lateral movement whileenabling longitudinal movement within the second channel and the secondchannel enabling access to the target tissue at an angle to alongitudinal axis of the first channel, wherein the second channel has awall longitudinally shared with the first channel.
 10. The system ofclaim 9, wherein the tissue holder comprises a suction device.
 11. Thesystem of claim 10, wherein the suction device includes a plunger havinga transverse distal plate, wherein proximal movement of the plungerpulls the target tissue proximally as the ligation device engages thetarget tissue.
 12. The system of claim 9, further comprising a lockingdevice including an engagement structure on the ligation deviceengageable with engagement structure of the anoscope to restrict one orboth of axial movement or rotational movement of the ligation devicewithin the anoscope.
 13. The system of claim 9, wherein the anoscope andthe second channel are configured so that a tip of the elastic bandligation device inserted through the second channel to the target tissueis positioned 2 cm to 2.5 cm from a distal edge of the anoscopepositioned at a dentate line of a patient.
 14. A method for applying anelastic band to a hemorrhoid tissue comprising a) providing an anoscopehaving a first longitudinal channel and a second channel integral withthe anoscope and extending at an angle to the first channel, the secondchannel extending within the first channel and the second channel havinga wall positioned in the first channel and longitudinally shared withthe first channel; b) inserting the anoscope through an anal canaladjacent the hemorrhoid tissue and anatomically proximal of a dentateline of a patient; c) inserting a ligating device through the secondchannel of the anoscope; and d) advancing the elastic band from theligating device onto the hemorrhoid tissue.
 15. The method of claim 14,further comprising a step of retracting an inner member of the ligatingdevice to suction the hemorrhoid tissue and retract the hemorrhoidtissue into the device and wherein the step of advancing the elasticband comprises the step of advancing an outer tube of the ligatingdevice in contact with the elastic band.
 16. The method of claim 14,further comprising a step of locking the ligating device to the anoscopeto restrict axial and rotational movement of the ligating device withinthe anoscope.
 17. The method of claim 14, wherein the anoscope and thesecond channel are configured so that when the anoscope is inserted so adistal edge is at the dentate line, a tip of the ligating deviceinserted through the second channel to contact a target tissue ispositioned 2 cm to 2.5 cm from the distal edge of the anoscope and thedentate line of the patient.
 18. The method of claim 14, wherein avertex of an imaginary triangle formed by an intersection of an extendedlongitudinal axis of the second channel and an extended edge of theanoscope is 2 cm to 2.5 cm from the dentate line of the patient.